REPRESENTATIVE EXPERIENCE
Michael J. Freno
Represented Par Pharmaceuticals, Inc. in a Hatch-Waxman patent lawsuit filed by Alsa Corp. involving Par's application to market an extended-release methylphenidate hydrochloride product. The parties settled. Par's Alza Corp. v. Par Pharm., Inc., No. 13-1104 (D. Del.).
Represented third-party intervenor Par Sterile Products, LLC in a lawsuit filed by Hospira, Inc. against FDA for approving Par's generic version of Precedex. Par successfully obtained a summary judgment within four weeks and defeated a preliminary injunction. Hospira Inc. v. Sylvia Mathews Burwell, No. 14-2662 (D. Md.).
Represented Cipla Limited and Cipla USA, Inc. in a patent infringement lawsuit filed against Sunovion Pharmaceuticals Inc. involving Sunovion's levalbuterol product. The parties settled before trial. Cipla Ltd. v. Sunovion Pharmaceuticals Inc., No. 15-cv-00424-LPS (D. Del.).
Represented Cipla Limited and Cipla USA, Inc. in a Hatch-Waxman patent infringement lawsuit filed by Abraxis Bioscience, LLC involving Cipla's paclitaxel product. Abraxis dismissed the action pursuant to a settlement. Abraxis Bioscience, LLC and Celgene Corp. v. Cipla Limited, No. 16-9074-JMV (D.N.J.).
Represented Cipla Limited and Cipla USA, Inc. in a Hatch-Waxman patent infringement lawsuit filed by Amgen involving Cipla's cinacalcet product. Amgen dismissed the action pursuant to a settlement. Amgen Inc. v. Aurobindo, et al., No. 16-cv-00880 and 16-853-GMS consolidated.
Representing Genus Lifesciences, Inc. in a trade secret misappropriation lawsuit filed against Mallinckrodt LLC involving Mallinckrodt's use of Genus's trade secrets to increase the value of Mallinckrodt's drug master file for cocaine. The case is pending. Genus Lifesciences, Inc. v. Mallinckrodt LLC and SpecGX, LLC, No. xx-cv-xxx (E.D. Pa.).
Representing a generic pharmaceutical company in a Lanham Act false advertising lawsuit against Lannett Company, Inc. involving Lannett's alleged false advertising of its C-Topical product (cocaine hydrochloride 4% solution). The case is pending. Genus Lifesciences, Inc. v. Lannett Company, Inc., No. 18-cv-07603-WHO (N.D. Cal.).
Represented Lehigh Valley Technologies, Inc.; Endo Global Ventures; Endo Ventures Limited; and Generics Bidco I, LLC in a Lanham Act false advertising lawsuit at the ITC against Virtus Pharmaceuticals, LLC involving Virtus’ alleged false advertising of its potassium chloride product. The case settled. Lehigh Valley Techs., Inc. v. Virtus Pharm. LLC, Inv. No. 337-TA-1013 (U.S.I.T.C.).
Represented Lehigh Valley Technologies, Inc.; Endo Global Ventures; Endo Ventures Limited; and Generics Bidco I, LLC in a Lanham Act false advertising lawsuit against Virtus Pharmaceuticals, LLC involving Virtus; alleged false advertising of its potassium chloride product. The case settled. Lehigh Valley Techs., Inc. v. Virtus Pharm. LLC, Inv. No. 16-cv-00435 (D. Del.).
Represented defendant Par Pharmaceuticals, Inc. in this Hatch-Waxman patent infringement lawsuit filed by Merck Sharp & Dohme Corp. involving Par's posaconazole product. Merck Sharp & Dohme Corp. v. Par Sterile Prods., LLC, No. 16-948 (D.N.J.).
Represented defendant Par Pharmaceuticals, Inc. and Anchen Pharmaceuticals, Inc. in this Hatch-Waxman patent infringement lawsuit filed by Forest Laboratories, LLC involving Par's generic version of Namzaric. Forest Laboratories, LLC, et al., v. Amneal Pharmaceuticals LLC, et al., No. 15-cv-00756-LPS (D. Del.).
Represented Par Sterile Products, LLC; Par Pharmaceutical, Inc.; and Par Pharmaceutical Companies, Inc. in a patent infringement lawsuit filed by Fresenius Kabi involving Par's levothyroxine product. Fresenius Kabi USA, LLC v. InnoPharma Licensing, LLC, et al., 15-cv-03655-KM (D.N.J.).
Represented Par Sterile Products, LLC in a patent infringement lawsuit filed by Novartis Pharmaceuticals Corp. involving Par's launch of a zoledronic acid product. Novartis dismissed the case pursuant to a settlement. In re: Certain Consolidated Zoledronic Acid Cases, No. 12-3967 (D.N.J.).
Represented defendant Par Pharmaceuticals, Inc. in this Hatch-Waxman patent infringement lawsuit filed by AstraZeneca, A.B. involving Par's saxagliptin product. AstraZeneca stipulated to the dismissal of all claims. AstraZeneca AB v. Aurobindo Pharma Ltd., et al., No. 14-cv-00664-GMS (D. Del.).
Represented Par Sterile Products, LLC in a Lanham Act false advertising lawsuit against Fresenius Kabi USA, LLC involving Fresenius's alleged false advertising of its vasopressin product. The case settled. Par Sterile Products, LLC v. Fresenius Kabi USA, LLC, No. 14-cv-03349 (N.D. Ill.).
Represented defendant Adamis Pharmaceuticals Corp. in this Hatch-Waxman patent infringement lawsuit filed by kaleo, Inc. involving Adamis's naloxone hydrochloride injection product. After two months, kaleo voluntarily dismissed the action. kaleo, Inc. v. Adamis Pharmaceuticals Corp., No. 19-cv-00917-RGA (D. Del.).